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The Cochrane Database of Systematic... Jun 2024Hepatocellular carcinoma is the most common type of liver cancer, accounting for 70% to 85% of individuals with primary liver cancer. Gene therapy, which uses genes to... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Hepatocellular carcinoma is the most common type of liver cancer, accounting for 70% to 85% of individuals with primary liver cancer. Gene therapy, which uses genes to treat or prevent diseases, holds potential for treatment, especially for tumours. Trials on the effects of gene therapy in people with hepatocellular carcinoma have been published or are ongoing.
OBJECTIVES
To evaluate the benefits and harms of gene therapy in people with hepatocellular carcinoma, irrespective of sex, administered dose, and type of formulation.
SEARCH METHODS
We identified randomised clinical trials through electronic searches in The Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE, Embase, LILACS, Science Citation Index Expanded, and Conference Proceedings Citation Index-Science. We searched five online clinical trial registries to identify unpublished or ongoing trials. We checked reference lists of the retrieved studies for further trials. The date of last search was 20 January 2023.
SELECTION CRITERIA
We aimed to include randomised clinical trials assessing any type of gene therapy in people diagnosed with hepatocellular carcinoma, irrespective of year, language of publication, format, or outcomes reported.
DATA COLLECTION AND ANALYSIS
We followed Cochrane methodology and used Review Manager to prepare the review. The primary outcomes were all-cause mortality/overall survival (whatever data were provided), serious adverse events during treatment, and health-related quality of life. The secondary outcomes were proportion of people with disease progression, adverse events considered non-serious, and proportion of people without improvement in liver function tests. We assessed risk of bias of the included trials using RoB 2 and the certainty of evidence using GRADE. We presented the results of time-to-event outcomes as hazard ratios (HR), dichotomous outcomes as risk ratios (RR), and continuous outcomes as mean difference (MD) with their 95% confidence intervals (CI). Our primary analyses were based on intention-to-treat and outcome data at the longest follow-up.
MAIN RESULTS
We included six randomised clinical trials with 364 participants. The participants had unresectable (i.e. advanced inoperable) hepatocellular carcinoma. We found no trials assessing the effects of gene therapy in people with operable hepatocellular carcinoma. Four trials were conducted in China, one in several countries (from North America, Asia, and Europe), and one in Egypt. The number of participants in the six trials ranged from 10 to 129 (median 47), median age was 55.2 years, and the mean proportion of males was 72.7%. The follow-up duration ranged from six months to five years. As the trials compared different types of gene therapy and had different controls, we could not perform meta-analyses. Five of the six trials administered co-interventions equally to the experimental and control groups. All trials assessed one or more outcomes of interest in this review. The certainty of evidence was very low in five of the six comparisons and low in the double-dose gene therapy comparison. Below, we reported the results of the primary outcomes only. Pexastimogene devacirepvec (Pexa-Vec) plus best supportive care versus best supportive care alone There is uncertainty about whether there may be little to no difference between the effect of Pexa-Vec plus best supportive care compared with best supportive care alone on overall survival (HR 1.19, 95% CI 0.78 to 1.82; 1 trial (censored observation at 20-month follow-up), 129 participants; very low-certainty evidence) and on serious adverse events (RR 1.42, 95% CI 0.60 to 3.33; 1 trial at 20 months after treatment, 129 participants; very low-certainty evidence). The trial reported quality of life narratively as "assessment of quality of life and time to symptomatic progression was confounded by the high patient dropout rate." Adenovirus-thymidine kinase with ganciclovir (ADV-TK/GCV) plus liver transplantation versus liver transplantation alone There is uncertainty about whether ADV-TK/GCV plus liver transplantation may benefit all-cause mortality at the two-year follow-up (RR 0.39, 95% CI 0.20 to 0.76; 1 trial, 45 participants; very low-certainty evidence). The trial did not report serious adverse events other than mortality or quality of life. Double-dose ADV-TK/GCV plus liver transplantation versus liver transplantation alone There is uncertainty about whether double-dose ADV-TK/GCV plus liver transplantation versus liver transplantation may benefit all-cause mortality at five-year follow-up (RR 0.40, 95% CI 0.22 to 0.73; 1 trial, 86 participants; low-certainty evidence). The trial did not report serious adverse events other than mortality or quality of life. Recombinant human adenovirus-p53 with hydroxycamptothecin (rAd-p53/HCT) versus hydroxycamptothecin alone There is uncertainty about whether there may be little to no difference between the effect of rAd-p53/HCT versus hydroxycamptothecin alone on the overall survival at 12-month follow-up (RR 3.06, 95% CI 0.16 to 60.47; 1 trial, 48 participants; very low-certainty evidence). The trial did not report serious adverse events or quality of life. rAd-p53/5-Fu (5-fluorouracil) plus transarterial chemoembolisation versus transarterial chemoembolisation alone The trial included 46 participants. We had insufficient data to assess overall survival. The trial did not report serious adverse events or quality of life. E1B-deleted (dl1520) adenovirus versus percutaneous ethanol injection The trial included 10 participants. It did not report data on overall survival, serious adverse events, or health-related quality of life. One trial did not provide any information on sponsorship; one trial received a national research grant, one trial by the Pedersen foundation, and three were industry-funded trials. We found five ongoing randomised clinical trials.
AUTHORS' CONCLUSIONS
The evidence is very uncertain about the effects of gene therapy on the studied outcomes because of high risk of bias and imprecision of outcome results. The trials were underpowered and lacked trial data on clinically important outcomes. There was only one trial per comparison, and we could not perform meta-analyses. Therefore, we do not know if gene therapy may reduce, increase, or have little to no effect on all-cause mortality or overall survival, or serious adverse events in adults with unresectable hepatocellular carcinoma. The impact of gene therapy on adverse events needs to be investigated further. Evidence on the effect of gene therapy on health-related quality of life is lacking.
Topics: Humans; Carcinoma, Hepatocellular; Liver Neoplasms; Randomized Controlled Trials as Topic; Genetic Therapy; Quality of Life; Bias; Male; Cause of Death; Female; Middle Aged
PubMed: 38837373
DOI: 10.1002/14651858.CD013731.pub2 -
Renal Failure Dec 2024This systematic review aimed to statistically profile the medication burden and associated influencing factors, and outcomes in patients with dialysis-dependent chronic... (Review)
Review
This systematic review aimed to statistically profile the medication burden and associated influencing factors, and outcomes in patients with dialysis-dependent chronic kidney disease (DD-CKD). Studies of medication burden in patients with DD-CKD in the last 10 years from 1 January 2013 to 31 March 2024 were searched from PubMed, Embase, and Cochrane databases. Newcastle-Ottawa Scale (NOS) or Agency for Healthcare Research and Quality (AHRQ) methodology checklist was used to evaluate quality and bias. Data extraction and combining from multiple groups of number (), mean, and standard deviation (SD) were performed using R programming language (version4.3.1; R Core Team, Vienna, Austria). A total of 10 studies were included, and the results showed a higher drug burden in patients with DD-CKD. The combined pill burden was 14.57 ± 7.56 per day in hemodialysis (HD) patients and 14.63 ± 6.32 in peritoneal dialysis (PD) patients. The combined number of medications was 9.74 ± 3.37 in HD and 8 ± 3 in PD. Four studies described the various drug classes and their proportions, in general, antihypertensives and phosphate binders were the most commonly used drugs. Five studies mentioned factors associated with medication burden. A total of five studies mentioned medication burden-related outcomes, with one study finding that medication-related burden was associated with increased treatment burden, three studies finding that poor medication adherence was associated with medication burden, and another study finding that medication complexity was not associated with self-reported medication adherence. Limitations: meta-analysis was not possible due to the heterogeneity of studies.
Topics: Humans; Renal Dialysis; Renal Insufficiency, Chronic; Peritoneal Dialysis; Medication Adherence
PubMed: 38832502
DOI: 10.1080/0886022X.2024.2353341 -
Experimental and Therapeutic Medicine Jul 2024The present study aimed to compare the differences between 3D-printed porous titanium and polyether ether ketone (PEEK) interbody fusion cages for anterior cervical...
Application of 3D‑printed porous titanium interbody fusion cage vs. polyether ether ketone interbody fusion cage in anterior cervical discectomy and fusion: A systematic review and meta‑analysis update.
The present study aimed to compare the differences between 3D-printed porous titanium and polyether ether ketone (PEEK) interbody fusion cages for anterior cervical discectomy and fusion (ACDF). Literature on the application of 3D-printed porous titanium and PEEK interbody fusion cages for ACDF was searched in the PubMed, Web of Science, Embase, China National Knowledge Infrastructure, Wanfang and VIP databases. A total of 1,181 articles were retrieved and 12 were finally included. The Cochrane bias risk assessment criteria and Newcastle-Ottawa scale were used for quality evaluation and Review Manager 5.4 was used for data analysis. The 3D cage group was superior to the PEEK cage group in terms of operative time [mean difference (MD): -7.68; 95% confidence interval (CI): -11.08, -4.29; P<0.00001], intraoperative blood loss (MD: -6.17; 95%CI: -10.56, -1.78; P=0.006), hospitalization time (MD: -0.57; 95%CI: -0.86, -0.28: P=0.0001), postoperative complications [odds ratio (OR): 0.35; 95%CI: 0.15, 0.80; P=0.01], C2-7 Cobb angle (MD: 2.85; 95%CI: 1.45, 4.24; P<0.0001), intervertebral space height (MD: 1.20; 95%CI: 0.54, 1.87; P=0.0004), Japanese Orthopaedic Association Assessment of Treatment (MD: 0.69; 95%CI: 0.24, 1.15; P=0.003) and visual analogue scale score (MD: -0.43; 95%CI: -0.78, -0.07; P=0.02). The difference was statistically significant, while there was no significant difference between the two groups in terms of fusion rate (OR: 1.74; 95%CI: 0.71, 4.27; P=0.23). The use of 3D-printed porous titanium interbody fusion cage in ACDF has the advantages of short operation time, less bleeding loss, shorter hospitalization time and fewer postoperative complications. It can better maintain the cervical curvature and intervertebral height, relieve pain and accelerate postoperative functional recovery.
PubMed: 38827472
DOI: 10.3892/etm.2024.12579 -
International Journal of Dental Hygiene Jun 2024Professional oral hygiene is essential to prevent peri-implant disease. Appropriate instruments should be employed for implant-supported restorations: they should... (Review)
Review
OBJECTIVES
Professional oral hygiene is essential to prevent peri-implant disease. Appropriate instruments should be employed for implant-supported restorations: they should effectively remove deposits without damaging dental implant surface. The aim of the present systematic review is to investigate the efficacy and safety of erythritol air-polishing in implant-supported rehabilitations, compared to alternative hygienic techniques.
MATERIALS AND METHODS
The guidelines reported in the indications of the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) were employed for this systematic review. The focused question was: 'what is the effect of erythritol air-polishing on dental implant surfaces regarding its cleansing efficacy and/or safety?' The final online search was conducted on 13 August 2023; MEDLINE-PubMed, Scopus and Cochrane Library were employed. Comparative in vitro or in vivo original studies were included.
RESULTS
The initial database search yielded 128 entries; the final selection comprised 15 articles. The risk of bias was evaluated using the Newcastle Ottawa scale (NOS), the Cochrane Handbook for Systematic Reviews of Interventions, GRADE method. Ultrasonic scaling with PEEK tips, glycine air-polishing and cold atmospheric plasma were the devices most frequently compared to erythritol powder in the included studies. Erythritol air-polishing appeared to be significantly more effective in reducing biofilm compared to other treatments, without causing any significant damage to the implant surface and peri-implant tissues, promoting a good biological response.
CONCLUSION
Erythritol air-polishing showed promising results for professional oral hygiene in implant-supported restorations. According to this systematic review, it is effective and safe for removing biofilm from titanium dental implants.
PubMed: 38825804
DOI: 10.1111/idh.12836 -
Clinical Microbiology and Infection :... May 2024Current guidelines recommend at least two weeks duration of antibiotic therapy (DOT) for patients with uncomplicated Staphylococcus aureus bacteraemia (SAB) but the... (Review)
Review
BACKGROUND
Current guidelines recommend at least two weeks duration of antibiotic therapy (DOT) for patients with uncomplicated Staphylococcus aureus bacteraemia (SAB) but the evidence for this recommendation is unclear.
OBJECTIVES
To perform a systematic literature review assessing current evidence for recommended DOT for patients with SAB.
METHODS
Data sources: We searched MEDLINE, ISI Web of Science, the Cochrane Database and clinicaltrials.gov from inception to March 30, 2024. References of eligible studies were screened and experts in the field contacted for additional articles.
STUDY ELIGIBILITY CRITERIA
All clinical studies, regardless of design, publication status and language.
PARTICIPANTS
Adult patients with uncomplicated SAB.
INTERVENTIONS
Long (>14; >18; 11-16 days) vs. short (≤14; 10-18; 6-10 days, respectively) DOT with the DOT being defined as the first until the last day of antibiotic therapy.
ASSESSMENT OF RISK OF BIAS
Risk of bias was assessed using the ROBINS-I-tool.
METHODS OF DATA SYNTHESIS
The primary outcome was 90-day all-cause mortality. Only studies presenting results of adjusted analyses for mortality were included. Data synthesis could not be performed.
RESULTS
Eleven non-randomized studies were identified that fulfilled the predefined inclusion criteria, of which three studies reported adjusted effect ratios. Only these were included in the final analysis. We did not find any RCT. Two studies with 1,230 patients reported the primary endpoint 90-day all-cause mortality. Neither found a statistically significant superiority for longer (>14; 11-16 days) or shorter DOT (≤14; 6-10 days, respectively) for patients with uncomplicated SAB. Two studies investigated the secondary endpoint 30-day all-cause mortality (>18; 11-16 days vs. 10-18; 6-10 days, respectively) and did not find a statistically significant difference. All included studies had a moderate risk of bias.
CONCLUSIONS
Sound evidence that supports any duration of antibiotic treatment for patients with uncomplicated SAB is lacking.
PubMed: 38823452
DOI: 10.1016/j.cmi.2024.05.015 -
Cureus Apr 2024is the primary microbe in the "periodontal red complex" bacteria (PRCB) along with and , which are linked to periodontal disease (PD). These pathogens are also... (Review)
Review
is the primary microbe in the "periodontal red complex" bacteria (PRCB) along with and , which are linked to periodontal disease (PD). These pathogens are also implicated in various systemic disorders, but their association with the incidence of gastrointestinal (GI) cancer is less explored. A systematic review followed by a meta-analysis was conducted as per standard guidelines (Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) 2022) to find this association between GI cancers and PRCB after a literature search for full-text papers in the English language (between 2010 and 2023) in databases (Cochrane Library, PubMed, and Web of Science) with suitable keywords using the Boolean search strategy. Data extraction involved titles, abstracts, and full texts retrieved and scored by the modified Newcastle-Ottawa Scale. The data were analyzed by the Review Manager (RevMan 5.2, Cochrane Collaboration, Denmark). Standard Cochran Q test and I statistics (for heterogeneity) and a random effects model (pooled OR with 95% CI) were applied to report results. among the PRCB was linked to GI cancers (OR: 2.16; 95% CI: 1.34-3.47). and did not show meaningful associations as per existing evidence for GI cancers.
PubMed: 38813341
DOI: 10.7759/cureus.59251 -
Journal of Oral & Maxillofacial Research 2024The purpose of this systematic review is to disclose the impact of autoimmune diseases and their medical treatment on dental implant survival and success. (Review)
Review
OBJECTIVES
The purpose of this systematic review is to disclose the impact of autoimmune diseases and their medical treatment on dental implant survival and success.
MATERIAL AND METHODS
A literature search was conducted using MEDLINE (PubMed), The Cochrane Library and Embase up to December 6, 2021. Any clinical study on patients with an autoimmune disease in whom implant therapy was performed was eligible. The quality of included studies was assessed using the Newcastle-Ottawa Scale. For each autoimmune disease group, data synthesis was divided into three groups: 1) overall results of the autoimmune disease, 2) overall results of corresponding control groups and 3) overall results of the autoimmune disease with a concomitant autoimmune disease (a subgroup of group 1). Descriptive statistics were used.
RESULTS
Of 4,865 identified articles, 67 could be included and mainly comprising case reports and retrospective studies with an overall low quality. Implant survival rate was 50 to 100% on patient and implant level after a weighted mean follow-up of 17.7 to 68.1 months. Implant success was sporadically reported. Data on immunosuppressive medication were too heterogeneously reported to allow detailed analysis.
CONCLUSIONS
Overall, a high implant survival rate was reported in patients with autoimmune diseases. However, the identified studies were characterized by a low quality. No conclusions could be made regarding implant success and the effect of immunosuppressants due to heterogeneous reporting.
PubMed: 38812949
DOI: 10.5037/jomr.2024.15101 -
Asian Pacific Journal of Cancer... May 2024To systematically review the existing scientific literature in providing a comprehensive, quantitative analysis on the prognostic ability of Cancer Associated... (Meta-Analysis)
Meta-Analysis
AIM
To systematically review the existing scientific literature in providing a comprehensive, quantitative analysis on the prognostic ability of Cancer Associated Fibroblasts (CAFs) in Oral Squamous Cell Carcinoma (OSCC) a novel meta-analysis.
METHODS
Review was performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines and registered in PROSPERO - CRD CRD42023467899. Electronic databases were searched for studies having data on effect of CAFs on overall survival rate and disease prognosis in patients with OSCC, oral epithelial dysplasia (OED) compared to normal healthy controls. Quality assessment of included was evaluated through Newcastle Ottawa scale (NOS) for included studies through its domains. The hazard ratio (HR) and risk ratio (RR) was used as summary statistic measure with random effect model and p value <0.05 as statistically significant.
RESULTS
Twenty studies fulfilled the eligibility criteria and were included in qualitative synthesis and eighteen studies for meta -analysis. Included studies had moderate to low risk of bias. It was observed through the pooled estimate that overall survival rate - (HR) =2.30 (1.71 - 3.10) was lesser in group with high CAFs compared to low CAFs while pooled estimate through RR =1.53 (0.73 - 3.19) and RR = 5.72 (2.40 - 13.59) signified that overall survival rate was lower n OSCC patients with high CAF compared to patients with OED and healthy controls. Publication bias through the funnel plot showed asymmetric distribution with presence of systematic heterogeneity indicating presence of publication bias.
CONCLUSION
Abundance of CAFs in tumor stroma of OSCC patients is associated with overall poor survival rate and poor disease prognosis. CAFs acts as a good prognostic and therapeutic marker in disease progression and advancements and should be assessed early to reduce patient's mortality and morbidity.
Topics: Humans; Mouth Neoplasms; Prognosis; Myofibroblasts; Carcinoma, Squamous Cell; Survival Rate; Biomarkers, Tumor
PubMed: 38809619
DOI: 10.31557/APJCP.2024.25.5.1477 -
International Journal of Colorectal... May 2024Circulating tumour DNA (ctDNA) has emerged as a promising biomarker in various cancer types, including locally advanced rectal cancer (LARC), offering potential insights... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
Circulating tumour DNA (ctDNA) has emerged as a promising biomarker in various cancer types, including locally advanced rectal cancer (LARC), offering potential insights into disease progression, treatment response and recurrence. This review aims to comprehensively evaluate the utility of ctDNA as a prognostic biomarker in LARC.
METHODS
PubMed, EMBASE and Web of Science were searched as part of our review. Studies investigating the utility of ctDNA in locally advanced rectal cancer (LARC) were assessed for eligibility. Quality assessment of included studies was performed using the Newcastle Ottawa Scale (NOS) risk of bias tool. Outcomes extracted included basic participant characteristics, ctDNA details and survival data. A meta-analysis was performed on eligible studies to determine pooled recurrence-free survival (RFS).
RESULTS
Twenty-two studies involving 1676 participants were included in our analysis. Methodological quality categorised by the Newcastle Ottawa Scale was generally satisfactory across included studies. ctDNA detected at various time intervals was generally associated with poor outcomes across included studies. Meta-analysis demonstrated a pooled hazard ratio of 8.87 (95% CI 4.91-16.03) and 15.15 (95% CI 8.21-27.95), indicating an increased risk of recurrence with ctDNA positivity in the post-neoadjuvant and post-operative periods respectively.
CONCLUSION
Our systematic review provides evidence supporting the prognostic utility of ctDNA in patients with LARC, particularly in identifying patients at higher risk of disease recurrence in the post-neoadjuvant and post-operative periods.
Topics: Humans; Biomarkers, Tumor; Circulating Tumor DNA; Disease-Free Survival; Neoplasm Recurrence, Local; Neoplasm Staging; Prognosis; Rectal Neoplasms
PubMed: 38809315
DOI: 10.1007/s00384-024-04656-1 -
Clinical Oral Investigations May 2024Prevention of atherosclerotic cardiovascular disease (ASCVD) is important in individuals with metabolic syndrome components (MetS), and periodontitis may play an... (Meta-Analysis)
Meta-Analysis
The role of periodontitis in the development of atherosclerotic cardiovascular disease in participants with the components of metabolic syndrome: a systematic review and meta-analysis.
OBJECTIVES
Prevention of atherosclerotic cardiovascular disease (ASCVD) is important in individuals with metabolic syndrome components (MetS), and periodontitis may play an important role in this process. This study aims to evaluate the association between periodontitis and ASCVD in participants with the components of MetS, including obesity, dysglycemia, hypertension, and dyslipidemia.
MATERIALS AND METHODS
This study conducted followed the MOOSE reporting guidelines and the PRISMA 2020 guidelines. EMBASE, MEDLINE, Web of Science, Cochrane Library, PubMed and OpenGrey were searched for observational studies about the linkage of periodontitis to ASCVD in people with MetS components up to April 9, 2023. Cohort, case-control and cross-sectional studies were included after study selection. Quality evaluation was carried out using the original and modified Newcastle-Ottawa Scale as appropriate. Random-effects model was employed for meta-analysis.
RESULTS
Nineteen studies were finally included in the quality analysis, and all of them were assessed as moderate to high quality. Meta-analyses among fifteen studies revealed that the participants with periodontitis were more likely to develop ASCVD in those who have dysglycemia (RR = 1.25, 95% CI = 1.13-1.37; p < 0.05), obesity (RR = 1.13, 95% CI = 1.02-1.24; p < 0.05), dyslipidemia (RR = 1.36, 95% CI = 1.13-1.65; p < 0.05), or hypertension (1.20, 95% CI = 1.05-1.36; p < 0.05).
CONCLUSIONS
Periodontitis promotes the development of ASCVD in participants with one MetS component (obesity, dysglycemia, hypertension or dyslipidemia).
CLINICAL RELEVANCE
In people with MetS components, periodontitis may contribute to the ASCVD incidence.
Topics: Metabolic Syndrome; Humans; Periodontitis; Atherosclerosis; Risk Factors; Hypertension; Dyslipidemias; Cardiovascular Diseases
PubMed: 38801482
DOI: 10.1007/s00784-024-05731-1